Resource Library

Any entities that plan to invest or are already invested in digital health companies, entities that contract with them, or providers that offer in-house telehealth modalities must be aware of the significant regulatory oversight the industry faces. This article discusses the US Department of Health and Human Services' Office of Inspector General's Special Fraud Alert published on July 20, 2022, which was the same day the US Department of Justice announced a massive fraud takedown, targeting telemedicine providers and physicians that netted criminal charges against 36 defendants in schemes that allegedly defrauded the government out of more than $1.2 billion.

Under the US Patent and Trademark Office’s (USPTO) new guidance on discretionary denial of institution of inter partes and post-grant (IPR and PGR, respectively) proceedings, a pending International Trade Commission (ITC) investigation is no longer a basis for the Patent Trial and Appeals Board (PTAB) to exercise its discretion to deny institution. This is a material change from past PTAB practice, which had previously denied institution of such post-grant proceedings due to an ongoing parallel ITC proceeding. This article discusses three considerations for ITC litigants given the USPTO’s new guidance.

In the wake of the US Supreme Court’s decision to overturn Roe v. Wade, the US Department of Health and Human Services (HHS) Office of Civil Rights (OCR) issued new guidance to address patient privacy under the Health Insurance Portability and Accountability Act (HIPAA) for those seeking reproductive health care services. This article discusses the guidance, which states that HIPAA allows providers to disclose certain protected health information (PHI), which includes information relating to one’s abortion or other reproductive care, without patient authorization only in specific circumstances that are “narrowly tailored to
protect the individual’s privacy and support their access to health services.”

On September 15, 2022, US Deputy Attorney General Lisa Monaco issued a memorandum outlining further revisions to the US Department of Justice’s (DOJ) criminal enforcement policies and practices. This article discusses DOJ’s two foundational expectations: prompt and transparent corporate self-disclosure and cooperation, and individual accountability.

Jeff Isaacs has given much thought to the evolution of legal services over his 30-plus year career in the industry, both in legal operations and as an attorney acting as both outside and in-house counsel. I recently had the opportunity to catch up with him on his career and his decision to join KPMG LLP as Director, Global Legal Managed Services. Click here to read more.

Learn about stricter terms entering into SMEs in the Netherlands.

Learn about the requirements for employers and with new directives and their states of progress in the EU.

Learn about the joint statement of Ofcom and the CMA to develop coherent approaches to online safety and competition in the UK.

Learn about key climate change challenges, strategies, and regulatory developments in the media sector in the United Kingdom and the European Union.

Learn about key regulatory developments and guidance at the intersection of competition law and sustainability in the European Union, the Netherlands, and the United Kingdom, in connection with calls for competition laws to support sustainability.